Daxas | European Medicines Agency (EMA)

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Product information

English (EN) (368.06 KB – PDF)

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български (BG) (482.86 KB – PDF)


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28/07/2010

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español (ES) (440.15 KB – PDF)


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čeština (CS) (517.67 KB – PDF)


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dansk (DA) (388.31 KB – PDF)


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28/07/2010

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Deutsch (DE) (399.2 KB – PDF)


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eesti keel (ET) (411.49 KB – PDF)


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28/07/2010

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ελληνικά (EL) (545.4 KB – PDF)


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28/07/2010

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07/10/2025

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français (FR) (519.3 KB – PDF)


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28/07/2010

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hrvatski (HR) (466.28 KB – PDF)


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28/07/2010

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íslenska (IS) (368.79 KB – PDF)


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italiano (IT) (428.11 KB – PDF)


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latviešu valoda (LV) (453.74 KB – PDF)


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lietuvių kalba (LT) (463.72 KB – PDF)


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magyar (HU) (520.6 KB – PDF)


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Malti (MT) (484.8 KB – PDF)


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28/07/2010

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Nederlands (NL) (502.11 KB – PDF)


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28/07/2010

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norsk (NO) (364.36 KB – PDF)


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28/07/2010

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polski (PL) (509.35 KB – PDF)


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28/07/2010

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português (PT) (402.16 KB – PDF)


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28/07/2010

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română (RO) (456.23 KB – PDF)


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28/07/2010

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07/10/2025

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slovenčina (SK) (459.49 KB – PDF)


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28/07/2010

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07/10/2025

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slovenščina (SL) (462.93 KB – PDF)


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28/07/2010

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Suomi (FI) (381.1 KB – PDF)


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28/07/2010

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svenska (SV) (413.47 KB – PDF)


First published:
28/07/2010

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Latest procedure affecting product information:VR/0000303126

06/10/2025

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This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

English (EN) (25.21 KB – PDF)

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български (BG) (26.29 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

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español (ES) (25.01 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

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čeština (CS) (24.7 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

dansk (DA) (25.52 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

Deutsch (DE) (24.84 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

eesti keel (ET) (26.27 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

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ελληνικά (EL) (26.15 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

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français (FR) (24.02 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

hrvatski (HR) (24.33 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

íslenska (IS) (25.88 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

italiano (IT) (24.23 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

latviešu valoda (LV) (25.01 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

lietuvių kalba (LT) (26.71 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

magyar (HU) (25.41 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

Malti (MT) (32.17 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

Nederlands (NL) (26.04 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

norsk (NO) (24.68 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

polski (PL) (24.72 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

português (PT) (24.59 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

română (RO) (25 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

slovenčina (SK) (24.74 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

slovenščina (SL) (24.61 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

Suomi (FI) (23.68 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

svenska (SV) (24.02 KB – PDF)


First published:
28/07/2010

Last updated:
25/04/2018

View

English (EN) (136.86 KB – PDF)

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български (BG) (156.76 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

español (ES) (124.5 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

čeština (CS) (152.19 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

dansk (DA) (146.66 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

eesti keel (ET) (126.95 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

ελληνικά (EL) (106.92 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

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français (FR) (162.9 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

italiano (IT) (117.58 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

latviešu valoda (LV) (145.63 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

lietuvių kalba (LT) (153.71 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

magyar (HU) (177.13 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

Malti (MT) (129.74 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

Nederlands (NL) (118.07 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

polski (PL) (149.7 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

português (PT) (121.4 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

română (RO) (141.48 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

slovenčina (SK) (168.79 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

slovenščina (SL) (136.3 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

Suomi (FI) (126.7 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

svenska (SV) (123.85 KB – PDF)


First published:
28/07/2010

Last updated:
28/07/2010

View

Product details

Name of medicine

Daxas

Active substance

roflumilast

International non-proprietary name (INN) or common name

roflumilast

Therapeutic area (MeSH)

Pulmonary Disease, Chronic Obstructive

Anatomical therapeutic chemical (ATC) code

R03DX07

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.

Product information – with tracked changes

The approved product information for this medicine is available below showing the changes since the previous procedure affecting the product information. The same document without tracked changes is above under ‘Product information’.

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